This technique is a novel superior based muscle sparing approach. Acetabular reaming in all hip approaches requires femoral retraction. This technique is performed through a hole in the lateral femoral cortex without the need to retract the femur.

A 5 mm hole is drilled in the lateral femur using a jig attached to the broach handle, similar to a femoral nail. Specialised instruments have been developed, including a broach with a hole going through it at the angle of the neck of the prosthesis, to allow the rotation of the reaming rod whilst protecting the femur. A special C-arm is used to push on the reaming basket. The angle of the acetabulum is directly related to the position of the broach inside the femoral canal and the position of the leg. A specialised instrument allows changing of offset and length without dislocating the hip during trialling.

Some instrumentation has been used in surgery but ongoing cadaver work is being performed for proof of concept. The ability to ream through the femur has been proven during surgery. The potential risk to the bone has been assessed using finite analysis as minimal. The stress levels for any diameter maintained within a safety factor >4 compared to the ultimate tensile strength of cortical bone.

The described technique allows for transfemoral acetabular reaming without retraction of the femur. It is minimally invasive and simple, requiring minimal assistance. We are incorporating use with a universal robot system as well as developing an electromagnetic navigation system. Assessment of the accuracy of these significantly cheaper systems is ongoing but promising.

This approach is as minimally invasive as is possible, safe, requires minimal assistance and has a number of other potential advantages with addition of other new navigation and simple robotic attachments.

Background

Artificial total knee designs have revolutionized over time, yet 20% of the population still report dissatisfaction. The standard implants fail to replicate native knee kinematic functionality due to mismatch of condylar surfaces and non-anatomically placed implantation. (Daggett et al 2016; Saigo et al 2017). It is essential that the implant surface matches the native knee to prevent Instability and soft tissue impingement. Our goal is to use computational modeling to determine the ideal shapes and orientations of anatomically-shaped components and test the accuracy of fit of component surfaces.

Introduction

Soft tissue balancing in total knee arthroplasty surgery may prove necessary to elevate patient satisfaction and functional outcome beyond the current fair average. A new generation of contact load sensors embedded in trial tibial liners provides quantification of loads, direction, and an indirect assessment of ligamentous tension. With this technology, quantified intra-operative balancing may potentially restore compartmental load distribution to a more physiological and functional degree.

INTRODUCTION

Most total knees today are CR or PS, with lateral and medial condyles similar in shape. There is excellent durability, but a shortfall in functional outcomes compared with normals, evidenced by abnormal contact points and gait kinematics, and paradoxical sliding. However unicondylar, medial pivot, or bicruciate retaining, are preferred by patients, ascribed to AP stability or retention of anatomic structures (Pritchett; Zuiderbaan). Recently, Guided Motion knees have been shown to more closely reproduce anatomic kinematics (Walker; Willing; Amiri; Lin; Zumbrunn). As a design approach we proposed Design Criteria: reproduce the function of each anatomic stabilizing structure with bearing surfaces on the lateral and medial sides and intercondylar; resected cruciates because this is surgically preferred; avoid a cam-post because of central femur bone removal, soft tissue entrapment, noises, and damage (Pritchett; Nunley). Our hypothesis was that these criteria could produce a Guided Motion design with normal kinematics.

INTRODUCTION

During TKA surgery, the usual goal is to achieve equal balancing between the lateral and medial side, which can be achieved by ligament releases or “pie crusting”. However little is known regarding a relationship between the balancing forces on the medial and lateral plateaus during TKA surgery, and the varus and valgus and rotational laxities when the TKA components are inserted. It seems preferable that the laxity after TKA is the same as for the normal intact knee. Hence the first aim of this study was to compare the laxity envelope of a native knee, with the same knee after TKA surgery. The second aim was to examine the relationship between the Varus-Valgus (VV) laxity and the contact forces on the tibial plateau.

INTRODUCTION

Understanding the biomechanics of the anatomical knee is vital to innovations in implant design and surgical procedures. The anterior – posterior (AP) laxity is of particular importance in terms of functional outcomes. Most of the data on stability has been obtained on the unloaded knee, which does not relate to functional knee behavior. However, some studies have shown that AP laxity decreases under compression (1) (2). This implies that while the ligaments are the primary stabilizers under low loads, other mechanisms come into play in the loaded knee. It is hypothesized this decreased laxity with compressive loads is due to the following: the meniscus, which will restrain the femur in all directions; the cartilage, which will require energy as the femur displaces across the tibial surface in a plowing fashion; and the upwards slope of the anterior medial tibial plateau, which stabilizes the knee by a gravity mechanism. It is also hypothesized that the ACL will be the primary restraint for anterior tibial translation.

Introduction

The intrinsic constraint of a total knee replacement (TKR) implant system is considered an important characteristic which plays a large role in determining stability following surgery. Established techniques for evaluating the constraint of TKR implants, as described in ASTM F 1223-14, do not necessarily map directly to physiologically relevant loading scenarios where instability can occur, and thus give an incomplete picture of the constraint characteristics of a candidate implant design. Sophisticated joint motion simulators now allow for more physiologically representative joint loading (eg. gait), including the contributions of virtual soft tissues. In this study, we employ a function-based constraint measurement technique for evaluating the kinematics of two TKR designs during gait. Furthermore, we employ simulated soft tissues in order to create three “virtual” knees on which the TKR are tested.

INTRODUCTION

Ligament balancing aims to equalize lateral and medial gaps or tensions for optimal functional outcomes. Balancing can now be measured as lateral and medial contact forces during flexion (Roche 2014). Several studies found improved functional outcomes with balancing (Unitt 2008; Gustke 2014a; Gustke 2014b) although another study found only weak correlations (Meneghini 2016). Questions remain on study design, optimal lateral-medial force ratio, and remodeling over time. Our goals were to determine the functional outcomes between pre-op and 6 months post-op, and determine if there was a range of balancing parameters which gave the highest scores.

Introduction

A correct balancing of the knee following TKA surgery is believed to minimize instability and improve patient satisfaction. In that respect, trial components containing force sensors can be used. These force sensors provide insight in the medial/lateral force ratio as well as absolute contact forces. Although this method finds clinical application already, the target values for both the force magnitude and ratio under surgical conditions remain uncertain.

INTRODUCTION

There are many factors which contribute to function after TKA. In this study we focus on the effect of varus-valgus (VV) balancing measured externally. A loose knee can show instability (Sharkey 2014) while too tight, flexion can be limited. Equal lateral-medial balancing at surgery leads to a better result (Unitt 2008; Gustke 2014), which is generally the surgical goal. Indeed similar varus and valgus laxity angles have been found in most studies in vitro (Markolf 2015; Boguszewski 2015) and in vivo (Schultz 2007; Clarke 2016; Heesterbeek 2008). The angular ranges have been 3–5 degrees at 10–15 Nm of knee moment, females having the higher angles. The goal of this study was to measure the varus and valgus laxity, as well as the functional outcome scores, of two cohorts; well-functioning total knees after at least one year follow-up, and subjects with healthy knees in a similar age group to the TKR's. Our hypothesis was that the results will be equal in the two groups.

INTRODUCTION

The role of soft tissue balancing in optimizing function and is gaining interest. Consistent soft tissue balancing has been aided by novel technologies that can quantify loads across the joint at the time of surgery. In theory, compressive load equilibrium should be correlated with ligamentous equilibrium between the medial and lateral collateral ligaments.

The authors propose to use the Coronal Angular Deviation Ratio (CADR) as a functional tool to quantify and track surgical changes in laxity of the collateral ligaments over time and correlate this ratio to validated functional scores and patient reported outcomes.

Unicompartmental knee replacements (unis) offer an early option for the treatment of osteoarthritis. However there is no standard method for measuring the wear of unis in the laboratory. Most knee simulators are designed for TKA, for which there is an ISO standard. This study is about a wear method for unis, applied to a novel unicompartmental knee replacement (design by PSW). It has a metal-backed UHMWPE femoral component to articulate against a monoblock metallic tibial component. The advantage is reduced resection of strong bone from the proximal tibia for more durable fixation. The femoral component resurfaces the distal end of the femur to a flexion arc of only 42°, the area of cartilage loss in early OA (Fig. 1). We compared this novel bearing couple to the same design but with the usual arrangement of femoral metal and tibial plastic. Our hypothesis was that the wear of the reversed materials would be comparable to conventional and within the range of TKR bearings.

The test was conducted on a 4-station Instron-Stanmore force-controlled knee simulator. Both specimen groups (n=4 each) were highly crosslinked UHWMPE stabilized with vitamin E. On each of the four stations, one uni system was mounted on the medial side and one on the lateral, as if a standard TKR was being tested. The ISO-14243-1 walking cycle force-control waveforms were applied for 5 million cycles (Mc) at 1Hz, but with the maximum flexion during the swing phase (usually 58°) curtailed to 35° to maintain the contact within the arc of the femoral component. In-vivo this implant would be inlaid into the distal medial femoral condyle and the articulating surface immediately transitions into native cartilage. In our test set-up there was no secondary surface as such. The reduced flexion occurred during the swing phase where compressive load was low and the effect on the wear would be negligible. Wear was measured gravimetrically at many intervals and corrected by the weight gain of extra two active soak controls per group.

After 5 Mc, the average rates of gravimetric weight loss from the UHMWPE femoral and tibial bearings were 4.73±0.266 mg/Mc and 3.07±0.388 mg/Mc, respectively (statistically significantly different, p=0.0007) (Fig. 2). No significant difference was found in wear between medial and lateral placement for specimens of the same type, although the medial side generally wore more. Although the plastic femorals of the reverse design wore more than the plastic tibials, the wear was still low at <5 mg/Mc. The range for typical TKRs using ultra-high molecular weight polyethylene, tested under the same conditions in our laboratory has been 2.85–24.1 mg/Mc.

In summary, we adapted the ISO standard TKA wear test for the evaluation of unis, and in this case, a uni with reversed materials. Based on the wear results, this type of ‘early intervention’ design could therefore be a viable option, offering simplicity with less modular parts as well as load sharing with the native articular cartilage.

A correct ligament loading following TKA surgery is believed to minimize instability and improve patient satisfaction. The evaluation of the ligament stress or strain is however impractical in a surgical setting. Alternatively, tibial trial components containing force sensors have the potential to indirectly assess the ligament loading. These instrumented components quantify the medial and lateral forces in the tibiofemoral joint. Although this method finds clinical application already, the target values for both the force magnitude and medial / lateral force ratio under surgical conditions remain uncertain.

A total of eight non-arthritic cadaveric knees have been tested mimicking surgical conditions. Therefore, the specimens are mounted in a custom knee simulator. This simulator allows to test full lower limb specimens, providing kinematic freedom throughout the range of motion. Knee flexion is obtained by lifting the femur (thigh pull). Knee kinematics are simultaneously recorded by means of a navigation system and based on the mechanical axis of the femur and tibia.

In addition, the load transferred through the medial and lateral compartment of the knee is monitored. Therefore, a 2.4 mm thick sawing blade is used to machine a slot in the tibia perpendicular to the mechanical axis, at the location of the tibial cut in TKA surgery. A complete disconnection was thereby assured between the tibial plateau and the distal tibia. To fill the created gap, custom 3D printed shims were inserted. Through their specific geometry, these shims create a load deviation between two Tekscan pressure pads on the medial and lateral side. Following the insertion of the shims, the knee was closed before performing the kinematic and kinetic tests.

Seven specimens showed a limited varus throughout the range of motion (ranging from 1° to 7° varus). The other knee was in valgus (4° valgus). Amongst varus knees, the results were very consistent, indicating high loads in full extension. Subsequently, the loads decrease as the knee flexes and eventually vanishes on the lateral side. This leads to consistently high compartmental load ratios (medial load / total load) in flexion.

In full extension the screw-home mechanism results in increased loads, both medially and laterally. Upon flexion, the lateral loads disappear. This is attributed to slackening of the lateral collateral ligament, in turn linked to the femoral rollback and slope of the lateral compartment. The isometry of the medial collateral ligament contributes on the other hand to the near-constant load in the medial compartment. The above particularly applies for varus knees. The single valgus knee tested indicated a higher load transmission by the lateral compartment, potentially attributed to a contracture of the lateral structures.

With respect to TKA surgery, these findings are particularly relevant when considering anatomically designed implants. For those implants, this study concludes that a tighter medial compartment reflects that of healthy varus knees. Be aware however that in full extension, higher and up to equal loads can be acceptable for the medial and lateral compartment.

During TKA surgery, the usual goal is to achieve equal balancing between the lateral and medial side, which can be achieved by ligament releases or “pie crusting”. However little is known regarding a relationship between the balancing forces on the medial and lateral plateaus during TKA surgery, and the varus and valgus and rotational laxities when the TKA components are inserted. It seems preferable that the laxity after TKA is the same as for the normal intact knee. Hence the first aim of this study was to compare the laxity envelope of a native knee, with the same knee after TKA surgery. The second aim was to examine the relationship between the Varus-Valgus (VV) laxity and the contact forces on the tibial plateau.

A special rig that reproduced surgical conditions and fit onto an operating table was designed (Verstraete et al. 2015). The rig allows application of a constant varus/valgus moment, and an internal-external (IE) torque. A series of heel push tests under these loading conditions were performed on 12 non-arthritic half semibodies hip-to-toe cadaveric specimens. Five were used for method development. To measure laxities, the flexion angle, the VV and the IE angle were measured using a navigation system. After testing the native knee, a TKA was performed using the Journey II BCS implant, the navigation assuring correct alignments. Soft tissue balancing was achieved by measuring compressive forces on the lateral and medial condyles with an instrumented tibial trial (Orthosensor, Dania Beach, Florida). At completion of the procedure, the laxity tests were repeated for VV and IE rotation and the contact forces on the tibial plateau were recorded, for the full range of flexion.

The average of the varus-valgus and the IE laxity envelope is plotted for the native (yellow), the TKA (pink) and the overlap between the two (orange). The average for six specimens of the contact force ratio (medial/medial+lateral force) during the varus and valgus test is plotted as a function of the laxity for each flexion angle.

The Journey II implant replicated the VV laxity of the native knee except for up to 3 degrees more valgus in high flexion. For the IE, the TKA was equal in internal rotation, but up to 5 degrees more constrained in varus in mid range. Plotting contact force ratio against VV laxity, as expected during the varus test the forces were clustered in a 0.85–0.95 ratio, implying predominant medial force with likely lateral lift-off. For the valgus test, the force ratio is more spread out, with all the values below 0.6. This could be due to the different stiffness of the MCL and LCL ligaments which are stressed during the VV test. During both tests the laxity increases progressively with flexion angle. Evidently the geometry knee reproduces more lateral laxity at higher flexion as in the anatomic situation.

There are many factors which contribute to function after TKA. In this study we focus on the effect of varus-valgus (VV) balancing measured externally. A loose knee can show instability (Sharkey 2014) while too tight, flexion can be limited. Equal lateral-medial balancing at surgery leads to a better result (Unitt 2008; Gustke 2014), which is generally the surgical goal. Indeed similar varus and valgus laxity angles have been found in most studies in vitro (Markolf 2015; Boguszewski 2015) and in vivo (Schultz 2007; Clarke 2016; Heesterbeek 2008). The angular ranges have been 3–5 degrees at 10–15 Nm of knee moment, females having the higher angles. The goal of this study was to measure the varus and valgus laxity, as well as the functional outcome scores, of two cohorts; well-functioning total knees after at least one year follow-up, and subjects with healthy knees in a similar age group to the TKR's. Our hypothesis was that the results will be equal in the two groups.

50 normal subjects average age 66 (27 male, 23 female) and 50 TKA at 1 year follow-up minimum average age 68 years (16 male, 34 female) were recruited in this IRB study. The TKA's were performed by one surgeon (PAM) of one TKA design, balancing by gap equalization. Subjects completed a KSS evaluation form to determine functional, objective, and satisfaction scores. Varus and valgus measurements were made using the Smart Knee Fixture (Borukhov 2016) at 20 deg flexion with a moment of 10 Nm.

The statistical results demonstrated that there was no significant difference in either varus or valgus laxity between the two groups (p= 0.9, 0.3 respectively). Pearson's correlation coefficient between varus and valgus laxity of the healthy group was 0.42, while for the TKA group was 0.55. In both cohorts varus laxity was significant higher than valgus laxity (p= 0.001^e−5 for healthy subjects and p=0.0001 for TKA). The healthy group had higher functional and objective KSS scores (p= 0.005^e−4, and p=0.004^e−5 respectively), but the same satisfaction scores as the TKA (p=0.3). No correlation was found between the total laxity of the TKA group and the KSS scores (functional, objective and satisfaction). Total laxity in females was significantly higher than in males in the healthy group, but no differences was found in the TKA group.

The hypothesis of equal varus and valgus angles in the 2 groups was supported. The larger varus angle implied a less stiff lateral collateral compared with the medial collateral. If the TKA's were balanced equally at surgery, it is possible there was ligament remodeling over time. However the functional scores were inferior for the TKA compared with normal. This finding has not been highlighted in the literature so far. The causes could include weak musculature (Yoshida 2013), non-physiologic kinematics due to the TKA design, or the use of rigid materials in the TKA. The result presents a challenge to improve outcomes after TKA.

Introduction

The major function of the medial meniscus has been shown to be distribution of the load with reduction of cartilage stresses, while its role in AP stability has been found to be secondary. However several recent studies have shown that cartilage loss in OA occurs in the central region of the tibia while the meniscus is displaced medially. In a lab study (Arno, Hadley 2013) it was confirmed that the AP laxity was greatly reduced with a compressive force across the knee, while the femur shifted posteriorly and the AP laxity was increased after a partial meniscetomy of the posterior horn. It is therefore possible that under load, the compression of the meniscus and the cartilage, 2–3mm in total, allows load transmission on the central tibial plateau, and causes radial expansion and tension of the meniscus providing restraint to femoral displacements. This leads to our hypotheses that the highest loading on the medial meniscus would be at the extremes of motion, rather than in the mid-range, and that the meniscus would provide the majority of the restraint to anterior-posterior femoral displacements throughout flexion when compressive loads were acting.

Total knee arthroplasty can largely impact the functioning of a knee. To minimize the impact of surgery and increase patient satisfaction, it is believed that restoring knee stability and control of the laxity has the potential to improve surgical outcome. In that respect, it is hypothesized that a well-balanced knee restores the native knee's laxity and stability, whereas unbalanced conditions result in an increased laxity and instability. This study intends to precisely evaluate knee laxity and stability in a cadaveric model in order to improve the clinical evaluation of the knee laxity under surgical conditions. This paper provides insight in the design considerations and methodology of a novel knee simulator and the preliminary results

In a first phase, a new knee simulator has therefore been developed. This simulator allows quantifying the knee kinematics and surgical feel at the time of surgery in a laboratory environment. More specifically, full lower limb specimens can be mounted in the simulator. This overcomes the need for disarticulation at the hip and ankle, often reported in cadaveric testing. The latter is believed to potentially release the tension in the knee and should therefore be avoided. Note that in respect to surgical conditions no muscle activation is considered for this simulator.

To facilitate a repeatable and unbiased evaluation of the knee kinematics, it is important that the knee simulator provides full kinematic freedom to the tested knee specimen. To obtain six degrees of freedom, a dedicated hip and ankle setup has been created (figure 1). The hip setup constrains the hip joint to a single axis hinge joint around the femoral head center. The remaining five degrees of freedom are built into the ankle setup. More specifically, the ankle setup has two translational degrees of freedom and full rotational freedom. The translational freedom is provided along the specimen's proximal-distal axis and medio-lateral axis. The rotational freedom is provided at a single point, using a ball in socket joint located along the mechanical axis of the tibia. The translation along the proximal-distal axis is thereby actively controlled by the operator, simulating heel push conditions. In addition to studying the neutral path kinematics, the presented simulator allows evaluating the laxity boundaries throughout the range of motion. Therefore, a constant internal/external torque can be applied to the tibia. Alternatively, a constant varus/valgus moment can be simulated.

Second, following the design and construction of this simulator, a set of ten cadaveric knees has been tested on this simulator, both before and after TKA surgery. For the native knees, the results of these tests confirm the kinematic freedom provided to the tested knee. In addition, the laxity envelope around the neutral path can be realistically evaluated and quantified.

PURPOSE

Soft tissue balancing can be achieved by using spacer blocks, by distractors which measure tensile forces, or by instrumented devices which measure the forces on the lateral and medial condyles. However there is no quantitative method for assessment of balancing at clinical follow-up; to address this, we developed a Smart Knee Fixture (SKF) which measured the varus and valgus angles for a moment of 10 Nm. Our purpose was to determine if varus and valgus angles measured at clinical follow-up, was equivalent to the balancing parameters of distraction forces or contact forces measured at surgery.

INTRODUCTION

Important surgical requirements for optimal function are accurate bone cut alignments and soft tissue balancing. From an unbalanced state, balancing can be achieved by Surgical Corrections including soft tissue releases, bone cut modifications, and changing tibial insert thickness. Surgical balancing can now be quantified using an instrumented tibial trial, but the procedures and results need further investigation. Our major purpose was to determine the initial balancing after making the bone cuts, and the final accuracy of balancing after Surgical Corrections. A related purpose was to determine the number and effectiveness of different Corrections in achieving balancing.

Introduction

The role of soft tissue balancing in optimizing functional outcome and patient satisfaction after total knee arthroplasty surgery is gaining interest. This is due in part to the inability of pure alignment to demonstrate excellent functional outcomes 6. Consistent soft tissue balancing has been aided by novel technologies that can quantify loads across the joint at the time of surgery 4. In theory, compressive load equilibrium should be correlated with ligamentous equilibrium between the medial and lateral collateral ligaments. The authors propose to use the Collateral Ligaments Strain Ratio (CLSR) as a functional tool to quantify and track surgical changes in laxity of the collateral ligaments and correlate this ratio to validated functional scores and patient reported outcomes. The relationship with intra-operative balancing of compartmental loads can then be scrutinized. The benefits of varus-valgus balancing within 2o include increased range of motion 7, whereas pressure imbalance between the medial and lateral joint compartments has been linked to condylar liftoff and abnormal kinematics post-TKA 8.

Introduction

The mechanical classical method of knee surgical instrumentation by alignment is based on built-in compromises and is considered insufficient to ensure consistent success. Soft tissue balancing is thus now seen as necessary for optimal functional outcomes and patient satisfaction. (Matsuda 2005, Winemaker 2002). The authors have previously demonstrated that balancing can be achieved through specific strategic moves. In this study, the goal was to determine the efficacy of a given surgical algorithm and to define predictors of improved outcome. The surgical target is equilibrium of contact loads. The mechanical axis remains in neutral, however subtle variation in the joint line obliquity and posterior slope are tolerated within the literature established boundaries of +/− 3 degrees and less than 10 degrees respectively.

PURPOSE

Soft tissue balancing can be achieved by using spacer blocks, by distractors which measure tensile forces, or by instrumented devices which measure the forces on the lateral and medial condyles. However there is no quantitative method for assessment of balancing at clinical follow-up; to address this, we developed a Smart Knee Fixture (SKF) which measured the varus and valgus angles for a moment of 10 Nm. Our purpose was to determine if varus and valgus angles measured at clinical follow-up, was equivalent to the balancing parameters of distraction forces or contact forces measured at surgery. METHODS: The SKF, which measured VV angles using stretch sensors on each side of the knee, was validated by cadaver studies, fluoroscopy, and emg. The balancing parameters were:

A force analysis, and measurements on 101 surgical cases & clinical follow-up in an IRB study, were carried out to determine the relationship between these parameters.

INTRODUCTION

The major loss of articular cartilage in medial osteoarthritis occurs in a central band on the distal femur, and in the center of the tibial plateau (Figure). This is consistent with varus deformity due to cartilage loss and meniscal degeneration, together with the sliding regions in walking. Treatment at an early stage such as KL grade 2 or 3, has the advantages of little bone deformity and cruciate preservation, and could be accomplished by resurfacing only the arthritic areas with Early Intervention (EI) components. Such components would need to be geometrically compatible with the surrounding bearing surfaces, to preserve continuity and stability. However because of the relatively small surface area covered, compared with total knees and even unicompartmentals, it is hypothesized that EI components will be an accurate fit on a population of knees with only a small number of sizes, and that accuracy can be maintained without requiring right-left components. We examined this hypothesis using unique design and methodology.

Introduction

The role of soft tissue balancing in optimising functional outcome and patient satisfaction after total knee arthroplasty surgery is gaining interest. Consistent soft tissue balancing has been aided by novel technologies that can quantify loads across the joint at the time of surgery. Based on free body diagram theory, compressive load equilibrium should be correlated with ligamentous equilibrium between the medial and lateral collateral ligaments. The authors propose to use the Collateral Ligaments Strain Ratio (CLSR) as a functional tool to quantify and track the effectuated surgical change in laxity of the medial and lateral collateral ligaments and correlate this ratio to validated functional scores and patient reported outcomes. The relationship with intra-operative balancing of compartmental loads can then be scrutinised.

Introduction

Balancing at surgery is important for clinical outcome in terms of pain relief, flexion range, and function. The methodology usually involves making bone cuts to achieve correct leg alignment, and then obtaining equal gaps in extension and flexion using spacer blocks or tensor devices. In this study, we describe a method for quantifying balancing throughout the flexion range and show the effect of different surgical corrections from an unbalanced to a balanced state. In this way, we quantified how accurately balancing could be achieved within the practical time frame of a surgical procedure.

Introduction

Evaluation of post-operative soft tissue balancing outcomes after Total Knee Arthroplasty (TKA) and other procedures can be measured by stability tests, with Anterior-Posterior (AP) drawer tests and Varus-Valgus (VV) ligamentous laxity tests being particularly important. AP stability can be quantified using a KT1000 device; however there is no standard way of measuring VV stability. The VV test relies on subjective force application and perception of laxity. Therefore we sought to develop and validate a device and method for quantifying knee balancing by analyzing VV stability.

The use of smart trial components is now allowing a better assessment of soft tissue balancing at the time of total knee replacement surgery. A balanced knee can be defined as one that possesses symmetry, ie. equal and centered lateral and medial forces through the full range of flexion. There is still a need for a standard reproducible surgical test to quickly confirm optimized balancing at surgery with such devices. The Heel Push test is the established standard, by pushing the foot in a cephalad direction while supporting the thigh and keeping the leg stable in the vertical plane. A common variation of this test is the Thigh Pull test where the foot is actively assisted during the cephalad pull of the thigh through deep flexion. The test is an open chain test. The Thigh Pull test may be an improvement since the weight of the leg is alleviated and no supplemental compressive forces are introduced. The directional changes of the lower extremity are thus a result of ligamentous tension and balances. The purpose of this study is to compare the two tests using a standard testing methodology and observe the variation in kinetic parameters in a controlled biomechanical setting.

A custom l rig was developed, which independently controls all six degrees of freedom about the knee joint. In addition a commercial navigation system was used to derive instantaneous alignment values and flexion angles between the tibia and femur. The pelvis was fixed to the table and the foot was fitted onto a low friction carriage along a slide rail. The knee design used was cruciate retaining. The pressure mapping system was a wireless tibial trial that provided magnitude of load per compartment.

The study is a preliminary cadaveric study reporting the data from two. In this experiment the leg was then tested with the Heel Push and Thigh Pull tests after obtaining optimum soft tissue balance of the cadaveric specimen. From this standard neutral state a series of single surgical variables were introduced to mimic common intra-operative surgical corrections. This was achieved through custom tibial liner and angle shims.

The results defied theoretical anticipation. Though the total contact forces with heel push were generally higher than with thigh pull, the relative load distribution between compartments did not follow a trend (see Figure 1). Furthermore in deeper flexion the persistence of relatively high contact pressures would suggest that ligaments still generate intra-articular forces despite the much weaker gravitational effect. The clinical relevance lies in the asymmetry of the load distribution between medial and lateral compartment for the two methods tested. The load asymmetry as tested by the Thigh Pull test may correspond to an open chain in swing phase. This asymmetry would force some axial rotation and tibial femoral alignment deviation that can significantly affect the forces at the time of heel strike. The Heel Push test would be more representative of the compressive forces in a closed chain mode as seen during the stance phase of gait.

There are many different approaches to achieving balancing in total knee surgery. The most frequently used method is to obtain correctly aligned bone cuts, and then carry out necessary soft tissue releases to achieve equal flexion and extension gaps. In some techniques, the bone cuts themselves are determined by the prevailing soft tissue status or the kinematics during flexion-extension. Navigation can provide quantitative data during these processes but so far, navigation is used in only in a minority of cases. However in recent years, new technologies have been introduced with lower cost and implementation time, allowing for more widespread use. Early studies have indicated that more reproducible balancing can be obtained, and that balancing has a positive effect on clinical outcomes. However the ability to measure balancing quantitatively during surgery, has raised the questions of the most systematic method for implementation during surgery, and the relative influence of various correcting factors. Further, the ideal balancing parameters with respect to varus-valgus ratios and the magnitudes during a full flexion range, have yet to be defined. Even if normative data is the target, there is scant data on this topic.

In our own laboratory, we carried out experiments on knee specimens where the various surgical variables were systematically investigated for their effect on varus-valgus balancing. Different tests were developed including the ‘Heel Push Test’ where lateral and medial contact forces were plotted as a function of flexion. Imbalances were achieved with either bone cut adjustments or soft tissue releases. The major finding was that adjustments of only 2 mms or 2 degrees could correct most imbalances. This was considered to be due to two effects; the pretension in the ligaments bringing the structure to the stiff part of the load-elongation curve, and the high values of the stiffness itself. Medial-lateral equality was the goal in this work, but recognizing that this may not be the situation in the normal knee. To answer this question, we developed a method for measuring the varus-valgus balancing in normal subjects, using a ‘Smart Knee Fixture’ with embedded stretch sensors. We validated this device using cadaveric specimens, and normal volunteers using fluoroscopy and electromyography. We are now applying the method in an IRB study to both normals and post-operative knee replacement cases. For the latter, the relation between operative data, and post-operative balancing will be studied, as well as the relation of balancing to functional outcomes.

This overall subject of balancing at surgery, and the post-operative effects, is open to extensive experimental research, and is predicted to result in improved outcomes.

Soft tissue balancing in total knee replacement may well be the determining factor in raising the fair patient satisfaction. The development of intelligent implants allows quantification of reactive loads to applied pressures. This can be tested in dynamic mode such as heel push test at surgery, or in static mode such as when testing for varus/valgus (VV) laxity of the collateral ligaments of the knee. We postulate that a well-balanced knee will have comparable if not equal load distribution across compartments in dynamic loading. When tested for laxity, we anticipate an equal or comparable response to VV applied loads under physiologic load range of 10–50N. This study sought to analyze the relationship between the kinematic (joint motion) and kinetic (force) effects to VV testing in the 0–15 degrees range of flexion. One goal was to demonstrate that testing the knee in locked extension (Screw Home effect) is unreliable and should be abandoned in favor of the more reliable VV testing at 10–15 degrees of flexion.

This is a preliminary cadaveric study utilizing data from two hemibodies. The pelvis was fixed in a custom test rig with open or closed chain lower leg testing capability along a sliding rail with foot VV translational. Forces were applied at the malleoli with a wireless hand held dynamometer. Kinematic analysis of the hip-knee-ankle (HKA) tibiofemoral angle was derived from a commercial navigation system with mounted infrared trackers. Kinetic analysis was derived from a commercially available sensor imbedded in a tibial trial liner. Balance was optimized by conventional methods with the use of the sensor feedback until loads were roughly symmetrical and VV testing yielded symmetrical rise in opposite compartments. The VV testing was then performed with the knees locked at the femoral side in axial rotation and translational motion in any plane. Sagittal flexion was pre-set at 0, 10, and 15 degrees and progressive load was applied.

Total Knee Arthroplasty (TKA), has now become a reliable, successful, and widely used treatment for osteoarthritis. Numerous reports indicate that for the majority of patients, the TKA lasts a lifetime with pain relief and the ability to perform most everyday activities. However there are a number of ways in which the procedure can be further improved, the focus here being on function. One of the problems in evaluating function is that it depends upon the inherent ability, motivation, and expectation of the patients. There are several well-used questionnaire systems which capture functional ability objectively. In the effort to simplify evaluation, a ‘forgotten knee’ evaluation has been introduced, the concept being that ‘the ideal TKA design’ would feel and function like a normal knee. Such a measure would include factors such as surgical technique, alignment, and rehabilitation, as well as the TKA design itself. Another approach to evaluation is to measure biomechanical parameters, such as in gait analysis and fluoroscopy, which evaluate kinematic or kinematic parameters, using normal controls for comparison. Nevertheless, such evaluations still include factors other than the TKA design itself, and do not apply to new designs.

The approach taken here for the evaluation of a new TKA design independent of other factors, is to measure the neutral path of motion and the laxity boundaries of the loaded knee on the application of shear and torque over a full range of flexion. The benchmark is the same kinematic data from the normal intact knee. The rationale has some analogy to the ‘forgotten knee’ in that if the laxity response of a design of TKA is the same as that of the anatomic knee itself, the behavior of that implanted knee in any functional condition will be indistinguishable from that of the anatomic knee itself. Such a testing concept has some similarities to the constraint test described in the ASTM standard. In this paper, a novel design algorithm is proposed for creating different design concepts. First, a general morphological form is formulated for each design concept, a Cam-Post PS, a Saddle-Ramp, and a Converging Condyle, all with overall anatomic-like surfaces. Each femoral component is then designed, which is then moved through the normal neutral path and laxity paths, which creates the tibial surface. The concepts are evaluated using a Desktop Knee Machine configured to move the knee dynamically through full flexion while applying combinations of compression, shear and torque; kinematic data being captured optically and plotted using custom software. The normal benchmark was obtained from 10 normal knee specimens, which showed the restraint of the medial femoral condyle to anterior displacement and the overall rollback and laxity laterally. Compared with standard CR and PS designs, the Guided Motion designs were seen to more closely resemble normal. It is proposed that this approach can result in designs which will more likely reproduce a ‘forgotten knee’ and achieve the optimal function for a given patient.

Balancing in total knee replacement is generally carried out using the feel and experience of the surgeon, using spacer blocks or distractors. However, such a method is not generally applicable to all surgeons and nor does it provide quantitative data of the balancing itself. One approach is the use of instrumented distractors, which have been used to monitor soft tissue releases or indicate a flexion cut for equal lateral and medial forces. More recently an instrumented tibial trial has been introduced which measures and displays the magnitude and location of the loads on the lateral and medial plateaus, during various manoeuvres carried out at surgery. The data set is then used by the surgeon to determine options, whether soft tissue releases or bone cut adjustments, to achieve lateral-medial equality.

The testing method consisted of mounting the femoral component rigidly in a fixture on the vertical arm of an MTS machine. The tibial component was fixed on to a platform which allowed varus-valgus correction, and where the component could be displaced or rotated in a horizontal plane. Two of each size times 4 sizes of production components were tested. Compressive forces from 0–400N in steps of 50N were applied and the readings taken. There were strong correlations between applied and measured forces with mean Pearson's Correlation Coefficient of 0.958.

The special tests under different conditions did not have any effect on the output values. The output data proved to be repeatable under Central Loading with a maximum standard deviation of ± 15.36N at the highest applied force of 400N. “Low battery” did not adversely affect the data. Applying the load steadily to maximum versus load-unload-zero tests produced similar results. Lubrication versus no lubrication tests produced no changes to the results. There was no cross talk of the electronics within the device when loaded on one condyle. For both central and anterior-posterior loading, the contact points were centered medial-lateral on the GUI display, and tracked contact point translation appropriately.

Anterior-posterior loading did create output load variance at the extremes. However, it enabled the validation of the relationship of the femur on the trial surface. In addition, malrotation would be indicated by the femur riding up on the anterior or posterior tibial edges, important for soft tissue tension in all flexion angles.

In conclusion, the sensors provided data which was accurate to well within a practical range for surgical conditions. In our separate experiments on 10 cadaveric leg specimens, even the same test under controlled conditions could produce variations of up to ± 30N. Hence the sensor outputs indicated whether or not the knee was balanced to that level of tolerance, while the contact point data would indicate contacts too close to the anterior or posterior of the tibial surface.

The purpose of balancing in total knee surgery is to achieve smooth tracking of the knee over a full range of flexion without excessive looseness or tightness on either the lateral or medial sides. Balancing is controlled by the alignment of the bone cuts, the soft tissue envelope, and the constraint of the total knee. Recently, Instrumented Tibial Trials (OrthoSensor) which measure and display the location and magnitude of the forces on the lateral and medial condyles, have been introduced, offering the possibly of predictive and quantitative balancing. This paper presents the results of experiments on 10 lower limb specimens, where the effects of altering the bone cuts or the femoral component size were measured.

A special leg mounting rig was fixed to a standard operating table. A boot was strapped to the foot, and the boot tracked along a horizontal rail to allow flexion-extension. The initial bone cuts were carried out by measured resection using a navigation system. The trial femoral component and the instrumented tibial trial were inserted, and the following tests carried out:

Sag Test; foot lifted up, the trial thickness chosen to produce zero flexion.

Heel Push Test; heel moved towards body to maximum flexion.

Varus-Valgus Test, AP and IXR Tests were also carried out, but not discussed here.

For an initial state of the knee, close to balanced, the lateral and medial contact forces were recorded for the full flexion range. The mean value of the contact forces per condyle was 77.4N, the mean in early flexion (0–60 deg) was 94.2N, and the mean in late flexion (60–120 deg) was 55.7N. The difference was due to the effect of the weight of the leg. One of the following Surgical Variables was then implemented, and the contact forces again recorded. 1.

Distal femoral cut; 2 mm resection (2 mm increase in insert thickness to preserve extension)

The differences between the condyle force readings before and after the Surgical Variable were calculated for low and high angular ranges. The mean values for the 10 knees of the differences of the above Surgical Variables from the initial balanced state are shown in the chart.

From literature data, the mean tension increase in one collateral ligament is close to 25N/mm up to the toe of the load-elongation graph, and 50N/mm after the toe. Hence in the initial balanced state, the collateral ligaments were elongated by 2–4 mm producing pretension. From the Surgical Variables data, up to 2 mm/2 deg change in bone cuts (or 3 mm femcom change), and collateral ligament releases up to 2 mm, would correct from any unbalanced state to a balanced state.

This data provides useful guidelines for the use of the Instrumented Tibial Trials at surgery, in terms of bone cut adjustments and ligament releases.

In different contemporary posterior-stabilized (PS) total knees, there are considerable variations in condylar surface radii and cam-post geometry. This is expected to result in differences in kinematics and functional outcomes in patients. The hypotheses of our study were: 1. Current PS design will show symmetric motion which is different from anatomic motion, and 2. An asymmetric PS design will produce motion closer to normal anatomic motion than symmetric designs.

A special machine was constructed which could implement the ASTM standard test on constraint, by measuring the laxities. The rational for the test is to predict functional laxity ranges which will affect the kinematics in vivo. The machine set the knee at the required flexion angles and applied combinations of compressive, shear, and torque forces, to represent a range of everyday activities. The femorotibial contact points, the neutral path of motion, and the AP and internal-external laxities were used as the motion indicators. The benchmark was the motion data from anatomic knee specimens tested under the same conditions.

Four contemporary PS designs with a range of geometries was selected for the tests, together with a design where the medial side was more constrained, the lateral side was less constrained, and the post was rounded. The output motions were compared between themselves, while all designs were compared with the anatomic data. The PS designs showed major differences in motion characteristics among themselves including the neutral path of motion and the AP and rotational laxities. These differences were related to the constraints of the condyles, and the cam-post designs. The four PS designs showed motion different from anatomic, including symmetric mediolateral motion, susceptibility to excessive AP medial laxity, and reduced laxity in high flexion. The asymmetric Guided Motion design alleviated some but not all of the abnormalities; in particular, while the lateral rollback with flexion and the near-constant position of the medial femoral condyle resembled anatomic behaviour, the rotational laxity was still limited in high flexion. The latter ws observed to be due to the ‘entrapment’ of the femoral condyles between the upwards posterior lip of the tibial plastic, and the posterior of the cam-post, a phenomenon seen on all designs.

The conclusion of the study is that an asymmetric PS design may provide a path to achieving a closer match to anatomic kinematics. This may improve functional outcomes, and even provide a better ‘feel’ to the patient. However, there are still inherent challenges in PS design to closely achieve this goal. Other design configurations have also been formulated which could even more closely reproduce anatomic motion. However a pre-clinical testing method such as presented here, is one method for evaluation and can be used hand-in-hand with computational methods to produce an optimal design. The importance of the benchmark of the anatomic knee and the identification of the important parameters of the ASTM standard, notably the neutral path of motion and the laxity about the neutral path, are important aspects of the design methodology.

Published investigations with custom short stems have reported very encouraging results (Walker, et al, 1). However, off-the-shelf (OTS) versions of shorter length prostheses has not met with the same success.

Several basic questions must be addressed. First, what is the purpose of a stem? Second, can stem length be reduced and if so by how much can this be safely done. Third, what are the effects of stem shortening and are there other design criteria which must take on greater importance in the absence of a stem to protect against implant aseptic failure.

To examine these issues a testing rig was constructed which attempts to simulate the in vivo loading situation of a hip, Fig. 1 (Walker, et, al.). Fresh cadaveric femora were tested with the femora intact and then with femoral components of varying stem length implanted to examine the distribution of stresses within the femur under increasing loads as a function of stem length. This was correlated with observations of prospective DEXA measurement of proximal femoral bone mass and implant migration following THR (Leali, 3). We then initiated a prospective multi-center study of a specific short stem design which included three geometric features to ensure initial implant stability. This report documents that after 2 years, in the first 200 stems implanted, this design has been shown to provide stability against subsidence, flexion/extetnsion and rotational forces. This is consistent with the findings of the in-vitro studies and identical to the previously published clinical results of a similarly designed full length version of this same stem.

Our studies indicated that a stem is not an absolute requirement in order to achieve a well functioning, stable implant. Initial stability can be achieved in the absence of a stem, by a “rest fit,” if adequate design features are incorporated. These studies also demonstrated that simply reducing the length of an existing implant to accommodate changes in surgical techniques may not be a reasonable or safe design change. Such shortened versions of existing stem designs must undergo rigorously in-vitro testing and clinical validation before being released for implantation.

Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The OrthoSensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.

A rig was designed for lower body specimens mounted on a standard operating table. SURGICAL TESTS were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, matching the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.

SURGICAL VARIABLES were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10 mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.

Testing was carried out on 10 full leg specimens. The Sag Test was the basic test for determining the thickness of the tibial insert. The Heel Push Test was then implemented from which force data throughout flexion was determined; followed by the Varus-Valgus Test. In a surgical case, this data will be used in a decision tree to identify which Surgical Variable required correction. In the experiments, by obtaining the above data for each SURGICAL VARIABLE in turn, we were able to determine a SIGNATURE for each SURGICAL VARIABLE. It was found that there was considerable variation in the force magnitudes between knees. However the SIGNATURES were sufficient to point to the specific SURGICAL VARIABLE requiring correction. In some knees, although there was a dominant SURGICAL VARIABLE, even after correcting for that, there was still an imbalanced state, requiring a second correction.

This research provided the fundamental principles and data for: 1.

Defining tests to be carried out at surgery, to obtain force data to determine the SURGICAL VARIABLE to correct.

Tibial component loosening is an important failure mode in unicompartmental knee arthroplasty (UKA) which may be due to the 6–8 mm of bone resection required or the limited surface area. To address component loosening and fixation, a new Early Intervention (EI) design is proposed which reverses the traditional material scheme between femoral and tibial components. That is, the EI design consists of a plastic inlay component for the distal femur and a thin metal plate for the proximal tibia. With this reversed materials scheme, the EI design requires minimal tibial bone resection compared to traditional UKA to preserve the dense and stiff bone in the proximal tibia. This study investigated, by means of finite element (FE) simulations, the potential advantages of a thin metal tibial component compared with traditional UKA tibial components, such as an all-plastic inlay or a metal-backed onlay. We hypothesized that an EI component would produce comparable stress, strain, and strain energy density characteristics to an intact knee and more favorable values than UKA components. Indeed, the finite element results showed that an EI design reduced stresses, strains and strain energy density in the underlying support bone compared to an all-plastic UKA component. Analyzed parameters were similar for an EI and a metal-backed onlay, but the EI component had the advantage of minimal resection of the stiffest bone.

INTRODUCTION:

The purpose of this study was to determine if a short femoral stem (Lima Corporate, Udine, Italy) would result in a strain distribution which mimicked the intact bone better than a traditional length stem, thereby eliminating the potential for stress-shielding.

Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The Orthosensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop the algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.

A rig was designed for lower body specimens mounted on a standard operating table. Surgical Tests were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, to match the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.

Surgical Variables were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.

In an actual surgical case, having obtained readings from the Surgical Tests, the data will be compared with the signatures of the Surgical Variables. This will then identify the Variable which needed correction. The Surgical Tests will be repeated and the readings should be closer to balanced. Further correction of another Variable is carried out if necessary. In early clinical cases, it was found that this method allowed for identification of how to reach a balanced state, and achieved soft tissue balancing in a quantitative way.

In order to emulate normal knee kinematics more closely and thereby potentially improve wear characteristics and implant longevity the Medial Pivot type knee replacement geometry was designed. In the current study the clinical and radiographic results of 50 consecutive knee replacements using a Medial Pivot type knee replacement are reported; results are compared to the Australian Orthopaedic Associations National Joint Replacement Registry. The patients' data were crossed checked against the registry to see if they had been revised elsewhere. After a mean follow-up of 9.96 years results show that the Medial Pivot Knee replacement provides good pain relief and functional improvement according to KSS and Womac scores and on subjective patient questionnaires. There was one minor revision; insertion of a patella button at 6.64 years FU. There were no major revisions; all implants appeared to be well fixed on standard radiographic examination. While the revision rate for the Medial Pivot knee according to the Australia Joint Registry results is higher compared to all other types of knee replacements in the registry, and to what is reported in the literature on the medial pivot knee, it is not in the current series. Revision rate was similar to what is reported on in the literature, but after a longer follow-up period. However, long term follow-up is required to draw definitive conclusions on the longevity of this type of implant.

INTRODUCTION

Total Knee Arthroplasty (TKA) is a durable procedure which allows most patients to achieve a satisfactory functional level, but there can be instability under stressful conditions. Instability is one cause of early revision, often due to misalignment or inadequate ligament balancing. Persistent instability may cause elevated polyethylene wear. Lower levels of instability may cause patient discomfort with certain stressful activities. Hence quantifying instability may have an important role in the functional evaluation of TKA. Several previous studies showed that accelerometers have advantages in kinematic studies including low cost, ease of application, and application to any activity. The aim of this study was to demonstrate the use of an accelerometer attached to the anterior of the tibia, as an evaluation of knee stability of TKA patients. It was postulated that accelerations between TKAs and normal controls will be different, which could indicate abnormal TKA kinematics involving instability, especially for high intensity activities.

In the large majority of cases of knee osteoarthritis (OA), total knee replacement (TKA) is the selected treatment, due to its proven durability, satisfactory function and familiarity of surgeons. However in recent years there has been an increase in the numbers of uni-compartmental knees used (UKA), due to more favorable follow-up, improved designs and techniques, quicker and better patient recovery, and less hospitalization costs. Designs have been produced for even lesser invasive components than UKA, including simple spacers, with mixed results. Recently, several studies have been carried out on the wear patterns on the femoral and tibial condyles in OA, showing that the main areas of cartilage loss occur on the distal end of the femur, that area engaged in walking activities, and over a large proportion of the tibial plateau. A study we carried out on the bone pieces resected at TKA surgery showed that no less than 22% of the cases could have been done with a device which resurfaced only the medial side. That figure would have been higher if the patients had been treated earlier, before cartilage wear and deformation had progressed. In a more recent study, we showed the progress of the wear of OA by analyzing MRI scans of 50 patients at various stages of OA. The cartilage wear occurred on areas which were initially the thickest on both the femur and the tibia. This was evidently associated with excessive contact stresses, while the menisci, if they had previously been spreading the load over a large area of the cartilage surfaces, were no longer functional. In this paper it is proposed that the treatment modality of OA could be carried out on a sliding scale, based on MRI analysis together with clinical factors including pain and disability. Early Intervention devices, including UKA, could be used much more frequently if the surgical technique was developed to be reliable, simple and reproducible. Specifically there is space for an Early Intervention device (EI) where only the distal end of the femur and the tibial surface are resurfaced. A design has been produced where a pocket is milled into the distal end of the femur to house a plastic runner, and a thin layer is resected from the proximal tibia for a metal plate with a special keel design. The advantages of such a design are ease of exposure, accurate and simple surgery, minimal tibial resection for long term fixation, reduced wear, and ease of restoration of the original joint line. The wear is assessed using a custom-made wear machine, while fixation is evaluated using FEA. It is proposed that such a device would add a valuable option for the treatment of symptomatic early OA where the functional level of the patient can be maintained, and the progress of OA possibly arrested.

Introduction

Pre-operative patient education prior to hip and knee arthroplasty is thought to be beneficial for patients in general, although the clinical effect is unproven. Pre-operative education is now standard practice in many orthopaedic units, including our own. Anecdotally, we found patients in the private sector to be more satisfied with their education than those in the public sector, despite very similar education programs. We set out to investigate this observation and establish whether there were differences in the perception of educational quality between these groups.

Introduction

In order to prepare hamstring autograft, suture fixation to the tendon is required to secure and handle the tendon during harvest and preparation. We use a simple, grasping suture which doesn't require suture of the tendon, thus saving time and avoiding violation of the graft itself. We present this technique, with results of mechanical testing compared to a standard whip suture, traditionally used to handle hamstring autograft.

Introduction

The MAKO Surgical Rio Robotic Arm utilizes the pre-op CT images to plan positioning of the uni-condylar and patella-femoral components in order to achieve the most desirable kinematics for the knee joint. We hypothesize that the anatomic matching surfaces and the cruciate retaining design of the Restoris knee will best replicate normal knee kinematics. We tested the healthy cadaveric knee versus the MAKO knee and the most common TKR designs in order to evaluate and compare the kinematic properties.

Total hip replacements have shown great benefits to patients through relief of pain and restoration of function. However, because of the extensive variation in the size and shape of the femoral canal, especially for the situation encountered in the revision hip arthroplasty, standard uncemented hip systems with a limited number of sizes are unable to provide an accurate fit in every case. This study showed clinical results of 112 primary total hip replacements and 158 revision total hip replacements, using custom made CAD-CAM (Computer Aided Design-Computer Aided Manufactured) hip prostheses inserted between 1992 and 1998.

For primary hip replacements, the implants were designed to produce proximal line-to-line fit with the femoral bone and to provide optimal biomechanical environment of the hip. The stem was HA coated, 53 males and 58 females were included. Mean age was 46.2 years (range 24.6yrs - 62.2 yrs). The average duration of the follow up was 24 years (10 – 17 years). The mean Harris Hip Score (HHS) was improved from 42.4 to 90.3, mean Oxford Hip Score (OHS) was improved from 43.1 to 18.2 and the mean WOMAC hip score was improved from 57.0 to 11.9. There was 1 revision due to failure of the acetabular components but there were no failures of the femoral components. In the whole follow-up period, the survival of the femoral stem alone was 100%.

For revision hip replacements, the implants were designed using our design strategies of graduate approach to different revision situation based on Paprosky's classification of femoral bone defect. The implants were HA coated; some of them had distal cutting flutes. A total of 158 patients (97 males and 61 females) who had operation between 1991 and 1998 were followed up, among them 138 cases were due to aseptic loosening, 6 cases were periprosthetic fractures and 14 cases were infection. The average age was 63.1 years (range 34.6 – 85.9 years). The minimum follow up was 10 years (range 10 – 12 years). The mean Harris Hip Score was improved from 44.2 to 89.3, mean Oxford Hip Score was improved from 41.1 to 18.2 and the mean WOMAC hip score was improved from 52.4 to 12.3 respectively. 6 cases required further revision surgery, among them 3 were due to aseptic implant loosening, the overall survivorship at ten years was 97%.

The CAD-CAM hip stems are able to provide optimal implant fixation and restore hip function for every patient regardless their original femoral shape, bone condition and biomechanics of the hip. The excellent medium to long term clinical results justifies the use of CAD-CAM custom hip stems.

‘High flexion’ polyethylene tibial tray inserts are available from total knee replacement (TKR) manufacturers. There is currently no published data available that examines how much extra knee flexion these new implants give or if there are any wear consequences for the change in design. The high flexion inserts are narrower posteriorly than standard inserts and have chamfers anteriorly and on the post in cruciate sacrificing designs.

This prospective randomised controlled trial of 100 patients undergoing posterior stabilised TKR compared knee flexion, measured intra-operatively by a computer navigation system, of the standard and high flexion trial inserts in the same knee. Patients were then randomised to receive either a standard or ‘high flexion’ definitive component and the stability assessed. The post-operative knee flexion of all patients was measured at six months.

High flexion inserts did not give significantly more knee flexion than standard inserts either per-operatively at the trial insert stage, or at six months post-op and resulted in marginally more anterior draw. The average per-operative difference in flexion between standard and high flex inserts measured in the same knee was 3.2° (range -4-18°) The average knee flexion at 6 months post op was 106° for both groups. The average change in knee flexion comparing pre and post op was 2.3° for the high flex group and 0.6° for the standard insert group.

Laboratory Tek scan contact pressure analysis at the surface of the standard and high flexion designs was not significantly different, but the thinner polyethylene of the high flexion design raises questions about wear characteristics. High flexion polyethylene inserts are probably not justified in terms of improved knee flexion, but may be a useful option in certain technical circumstances during TKR such as patella baja or if the patella impinges on the post in deep flexion.

Introduction: For longer lasting and bone conserving cementless stem fixation, stable and physiological proximal load transfer from the stem to the canal should be one of the most essential factors. According to this understanding, we have been developing a custom stem system with lateral flare and an off-the-shelf (OTS) lateral flare stem system was added to the series. On the other hand, dysplastic hips are often understood that they have larger neck shaft angle as well as larger anteversion. In other words they are in the status called “coxa valga.” From this point of view we had been mainly using custom stems for the dysplastic cases before. After off-the-shelf lateral flare stem system; which is designed to have very high proximal fit and fill to normal femora; was added, we have been using 3D preoperative planning system to determine custom or OTS. Then in most of the cases, OTS stem were suitably selected. Our pilot study of virtual insertion of OTS lateral flare stem into 38 dysplastic femora has shown very tight fit in all 38 cases. The reason was analyzed that the excessive anteversion is twist of proximal part over the distal part and the proximal part has almost normal geometry. In the present study, 59 femora were examined by the 3D preoperative planning system how the excessive anteversion effect to the coxa valga status.

Materials and Methods: Fifty-nine femoral geometry data were examined by the 3D preoperative planning system. Thirty-three hip arithritis, 3 RA, 2 metastatic bone tumours, 5 AVN, 1 knee arthritis, 12 injuries, and 3 normal candidates were included. Among them one arthritic Caucasian and one AVN South American were included. The direction of the femoral landmarks; centre of femoral head (CFH), lesser trochanter (LTR), and asperas in 3 levels (just below LTR, upper 1/3, mid femur; A1-3); were assessed as the angle from knee posterior condylar (PC) line. Neck shaft angle of each case was assessed from the view perpendicular to PC line and neck shaft angle form the view perpendicular to CFH and femoral shaft (i.e. actual neck shaft angle).

Results: Average anteversion was 34.4 +/−9.9 degree. CFH and LTR correlated well (i.e. they rotate together). A1, A2, A3 correlated well (i.e. they rotate together). LTR and A1 correlate just a little, LTR and A2 were independent each other. So the twist existed around A1. Neck shaft angle was 138.7+/−6.6 in PC line view and in actual view 130.3+/−4.4. No excessive neck shaft angle was observed in actual view. Even the case that has the largest actual neck shaft angle (140.4), the virtual insertion showed good fit and fill with the lateral flare stem.

Conclusion: In many high anteversion cases, coxa valga is a product of the observation from non perpendicular direction to CFH-shaft plane. Selection or designation of the stem for high anteversion cases should be carefully determined by 3D observation.

Over the last two decades, design modifications in cementless total hip arthoplasty have led to longer lasting implants and an increased success rate. However, there remains limitations to the cementless femoral stem implant. Traditional cementless femoral components require large amounts of bone to be broached prior to stem insertion (1). This leads to a decrease in host bone stock, which can become problematic in a young patient who may eventually require a revision operation during his or her lifetime. Osteopenia, only second to distal stress shielding can lead to aseptic loosening of the implant and stem subsidence, which also accelerates the need for a revision operation (2–4). Recent literature suggests that thigh pain due to distal canal fixation, micro-motion, uneven stress patterns or cortex impingement by the femoral stem is directly correlated to increased stem sizes and often very disabling to a patient (5–8). In this study, we sought to determine whether reducing stem length in the femoral implant would produce more physiologic loading characteristics in the proximal femur and thus eliminate any remaining stress shielding that is present in the current design. We analyzed the surface strains in 13 femurs implanted with

no implants,

Analysis of the resulting surface strains was performed using the photoelastic method. For each femur, intact and with the different stem length components in place, the fringe patterns were compared at the same applied loads. The highest fringe orders observed for all tests were located on the lateral proximal femur and medial proximal femur. The fringes decreased as they approached the neutral axis of bending (posterior and anterior). Distal fringe patterns were more prominent as the stem length increased. The results demonstrate that the stemless design most closely replicated normal strain patterns seen in a native femur during simulated gait. The presence of a stemless, ultra short and short stem reduced proximal strain and increased distal strain linearly, thereby increasing the potential for stress shielding. The stemless design most closely replicated normal strain patterns observed in a native femur and for this reason has the potential to address the shortcomings of the traditional cementless femoral implant.

Recent trends in surgical techniques for THR, i.e. MIS and anterior approaches, have spawned an interest in and possible need for shorter femoral prostheses. Although, previously published clinical investigations with custom short stems have reported very encouraging results (Walker, et al, 1,2), the transition to off-the-shelf (OTS) versions of shorter length prostheses has not met with the same degree of success. Early reports with OTS devices have documented unacceptably high and significant incidences of implant instability, migration, mechanical/aseptic failure, and technical difficulty in achieving reproducible implantation outcomes. They have highlighted the absolute need for a better understanding of the consequences of changes in implant design as well as for improvements in instrumentation and surgeon training.

Several basic questions must be addressed. First, what is the purpose of a stem? Second, can stem length be reduced and if so by how much can this be safely done. Third, what are the effects of stem shortening and are there other design criteria which must take on greater importance in the absence of a stem to protect against implant failure.

To examine these questions a testing rig was constructed which attempts to simulate the in vivo loading situation of a hip, fig.1(Walker, et, al.). Fresh cadaveric femora were tested with the femora intact and then with femoral components of varying stem length implanted to examine the distribution of stresses within the femur under increasing loads as a function of stem length. This was correlated with observations of prospective DEXA measurement of proximal femoral bone mass and implant migration following THR(Leali, 3).

Our studies indicated that a stem is not an absolute requirement in order to achieve a well functioning, stable implant. However in order to reduce the possibility of mechanical failure a reduced stem or stemless implant absolutely must have, inherent to its design, a provision for sufficient contact with both the medial and lateral proximal metaphyseal femur. As well it must also have a flat posterior surface parallel to, and in contact with, the posterior surface of the proximal femoral metaphysis. These conditions will provide support against distal migration as well as bending moments in the A/P plane. As a consequence of this latter condition, appropriate anteversion must be achieved in the neck region of the prosthesis and not by rotation of the implant within the proximal metaphyseal cavity of the femur.

In conclusion, this study demonstrates that simply reducing the length of an existing implant to accommodate changes in surgical techniques may not be a reasonable or safe design change. Such shortened versions of existing stem designs should undergo rigorously in vitro testing before being released for implantation.

Intro: Anatomical abnormality associated with severe developmental dysplasia of the hip presents technical difficulties at THR. Patients often present at a younger age and may have had previous surgery.

We report the difficulties encountered during surgery, and the long term results of patients who had Crowe 3 or 4 DDH and a technically difficult primary hip arthroplasty using the modular S-ROM stem.

Method: 28 patients were entered into the prospective trial. The average age of the patient at surgery was 45 (range 23–74 years). All patients underwent surgery by the senior author using the S-ROM femoral stem. They were followed up for an average of 10 years (range 5–16 years), clinical scores recorded by a clinician other than the surgeon and radiographs were examined by an independent radiologist.

Results: 21 patients required a significant autologous bone graft, one patient had a large allograft and six patients required femoral shortening at the time of their THR.

4 patients had a technical complication during surgery. The average pre-op Harris Hip Score was 37, at 5 years it was 83, and at 10 years 81. The SF12 measure of physical and mental wellbeing was 43.90 physical/54.48 mental at 5 years, and 41.64 physical/54.03 mental at 10 years. The WOMAC average score (the lower the score the better the outcome) was 27 at 5 years and 23 at 10 years.

None of the S-ROM stems had been revised, 2 hips had undergone acetabular revision and one hip had a liner exchange. None of the S-ROM stems were loose at latest follow-up. Four hips had osteolysis in Gruen zone 1, one hip had osteolysis in zone 7, and one hip had osteolysis in zone 1 and 7. There was no evidence of osteolysis around or distal to the sleeve.

Conclusion: The S-ROM stem used in primary THR shows excellent results at 10 years in patients with anatomical abnormality related to severe DDH.

S-ROM stem/sleeve modularity allows femoral component anteversion independent of the position of best fit in the proximal femur, and helps overcome the technical difficulty in these patients.

Since 1993, we have been developing preoperative planning system based on CAT scan data. In early period it was used to decide cup diameter and orientation for Total Hip Arthroplasty (THA). It was done using hemisphere object locating proper position and orientation. According to our progress, we have started using it for custom stem designing, stem selection and stem size planning too since 1995. Since 2001, we have been using it for almost all THA cases. We also have started use it for any case we have question about 3D geometries. Since 2005 we started computer planed 2 staged THA after leg elongation for high riding hips and reported at ISTA 2007 too. Now our policy became that every tiny question we have, we shall analyze and plan preoperatively.

In our population, the incidence of the developmental dysplastic hips is higher. The necks often have bigger anteversion, and less acetabular coverage. So we often use screws for cup fixation. The screw direction allowed in thin shell thickness is limited and less bone coverage makes good cup fixation difficult. With highly defected cases and with revision cases the situation is more difficult.

In the present study, we have developed acetabular 3D preoperative planning method with screw direction, length, and for the cases with defect, cup supporter pre-shaping with models and prediction of the allograft volume.

For the less defect cases, geometries of cup with screw holes were requested to the maker and were provided for us. Screws were attached perpendicular to each screw hole. Screw geometries have marks at every 5mm to plan proper length. The cup was located as much as closer to the original acetabular edge, keeping in the limit to avoid dislocation. Small space above the cup was accepted if anterior and posterior cup edge could be supported by original bone. Then the cup was rotated until we can obtain proper screw fixation.

For the cases with severe defects, we use cup supporters and allografts. Cup supporters are designed to be bent and fit to the pelvis during the surgery. But to shape it a properly; for good coverage and strong support; is very difficult and takes long through the limited window with fatty gloves. And mean while we get more bleeding. The geometries were obtained by CAT scan of the devices. Then proper size was determined as cup size. Chemiwood model was made and proper size supporter was opened and bent preoperatively using the model. It was scanned again and compared to the pelvic geometry again.

Using cluster cups, no dangerous screw was found as long as normal cup orientation was decided and screws were less than 30mm. Posterior screws were often too short then rotated anterior and found to have good fixation. Pre-bending could reduce surgical time remarkably.

As long as we could know, no navigation system can control the cup rotation. But acetabular preoperative planning was very useful and could reduce operative invasion. It could be done easily without using navigation system.

Intro: Total knee replacement (TKR) manufacturers offer the option of high flexion tibial tray inserts. The polyethylene is narrower posteriorly than the standard insert and comes with the theoretical risk of reduced longevity due to thinner implant. This trial studied both the intra-operative and post-operative difference in knee flexion.

Method: 100 consecutive patients undergoing posterior stabilized Genesis II TKR with Brainlab navigation were studied. The flexion of each knee was assessed per-operatively using the Brainlab navigation system for both the high flex and standard tibial insert trials. Patients were then randomized to receive either a high flex or standard definitive implant and the knee flexion measured clinically with a goniometer six months post op.

Results: Intra-operatively the high flexion insert trial flexed more than the standard flex option by 3.2 degrees. Clinically at six months post op there was no difference in knee flexion between the two groups.

Conclusion: There is no clinical difference in knee flex-ion at six months post-op in patients with a high flex or standard tibial insert. However, we believe that in certain technical circumstances the high flex option is a valuable option for the surgeon to have available.

Introduction: Conservative hip replacements are advantageous because resection of bone in the proximal femur is minimised. This study investigated a new design of conservative hip in the goat model where the femoral head was resected and two hydroxyapatite coated ‘pegs’ were introduced into the femoral neck. The hypothesis was that the ‘pegs’ would provide a direct method of transmitting forces within the femoral neck thus resulting in less adverse bone remodelling and reduced loosening. Bone stock is also preserved should subsequent revision be required.

Methods: Eight unilateral implants were inserted into the right femur of adult female goats for 1 year. Retrieved specimens were analysed radiographically and histologically. Image analysis was used to quantify bone attachment and total bone area adjacent to the implant. Tetracycline bone markers quantified bone turnover. Operated hips were compared with non-operated hips. The students t-test was used for comparative statistical analysis where p< 0.05 were classified as significant.

Results: Radiographic analysis demonstrated bone loss beneath the cup with increased bone density at the distal end of the pins (fig.1). Light microscopy revealed areas of new and mature bone adjacent to the implant. Osseointegration to the HA coating was observed. Bone markers established significantly decreased bone formation rates (p< 0.05) in bone adjacent to the implant in the operated versus control hips.

Image analysis results demonstrated an average bone attachment of 30.94% to the implant surface (fig 2). Greatest bone attachment occurred at the end of the pins (78.99%) contributing 22% of overall attachment to the implant. Least attachment occurred beneath the prosthetic cup (13.82%) and in the medial aspect adjacent to the central pin. Greater total bone area was measured in control hips and no significant correlation between bone attachment to the ‘pegs’ and bone area beneath the prosthetic cup was identified.

Discussion: From this study we have concluded that despite the resorption of bone beneath the prosthetic cup, the conservatve hip design investigated remained well fixed in the femur during the 1 year in vivo period. It appears that an implant design that resurfaces the femoral head with two pins used to transmit forces into the femoral neck is a useful approach in conservative hip design.

Background: The Profix Total Knee Arthroplasty (Smith and Nephew, Memphis, USA) is designed to replace less bone than is resected from the posterior femoral condyles, and as a consequence the posterior condylar offset is reduced. The net effect of this is to increase the flexion gap with no effect on the extension gap. This is a deliberate design philosophy aimed at increasing postoperative flexion. This prospective cohort study has tested this theory.

Methods: 60 patients underwent primary posterior cruciate retaining (CR) TKA using this prosthesis. A matched group of patients, employing a different CR prosthesis which replaces excised bone in full, served as historical controls. Intra-operative measurements were made of the posterior condylar bone resected in each case. These measurements were then correlated with the flexion achieved both intra-operatively and at 6 months post-operatively.

Results: A positive correlation between pre-operative and post-operative flexion was found. However, there was no correlation between the relative increase in flexion gap secondary to the reduction in posterior offset and the resulting flexion range.

Conclusion: Post-operative flexion range is not increased by the resection of more bone from the posterior femoral condyles than is replaced by the prosthesis in TKA. The loss of bone stock will have implications for revision surgery and should be avoided.

Knee simulators are now widely used for the determination of performance and wear durability of TKR’s. The International Standards Organisation (ISO) force-control option synchronises AP force and IE torque with flexion angle and axial force for the walking gait cycle. The force control concept subjects the same input waveforms to different TKRs, allowing them to move (and wear) as their designs dictate. It however relies on a mechanical spring based assembly to simulate the restraint effects of ligaments in AP and rotation. The contribution of this restraint mechanism depends on the stiffnesses of the four springs, and on how they are set at the neutral position. The springs can be loose with a gap, such that compression only starts (or ends) when the motion exceeds the gap. Alternatively the springs can be pre-compressed such that they never go loose.

A detailed mathematical model was developed which included the stiffnesses of the four springs, their settings (level of pre-compression or gap), and geometry of the mechanism to calculate a matrix of AP restraint force curves with AP displacement, and how these curves change with int-ext rotation superimposed. The same was done for rotational restraint with simultaneous linear displacement. Through an interactive computational interface, the families of curves for any combination of variables were repeatedly plotted and compared to published data on the contribution of particular ligaments to the laxity of the knee (eg. Fukubayashi et al. 1982) to find the optimum spring stiffnesses and gap configuration. This was done for simulation arrangements retaining ACL, PCL or both retained or resected. The results showed the behaviour of the system to be as sensitive to the gap and level of pre-compression, as to the stiffnesses of the springs. For the resected ACL retained PCL situation, the optimum we recommend is soft (7.24 N/mm) springs on the ACL side, harder (33.8 N/mm) springs on the PCL side, with a 2.5 mm gap on each side. For both ACL and PCL resected, the soft (7.24 N/mm) springs for both sides are optimum, again with a 2.5 mm gap on each.

These settings are obviously different from each other, and are different from the tests with this simulator published by different laboratories. The same settings are a pre-cursor for valid comparison of wear and kinematics.

Besides the numerous variations of TKR designs addressing fixation, wear, or specific indications, there are variations from competing design philosophies such as conformity and shape of the articulating surfaces and mobile versus fixed bearing designs. With the same resected ACL and retained PCL ligament combinations and similar surgical procedure, the subset of different implants for these very indications should be expected to produce only minor variations in kinematics. This study set out on a comprehensive series of detailed and intricately controlled in-vitro tests to examine this hypothesis. Six different posterior cruciate retaining medium size knees from different manufacturers were used. Four were fixed bearing condylar types of low to high constraint; and two mobile bearing ones which allowed rotational and translational freedom, one fully and one partially conforming. The implants were aligned according to the manufacturer’s recommendations and subjected to the same ISO force-control simulation. The kinematics captured from the averaged simulated cycles of walking showed AP displacement contained within an envelope of 4 mm for most of the stance phase. This increased with most to a maximum range of 5mm just before toe-off at the end of the stance phase. In rotation, the designs showed ranges during stance from about 2–13 degrees. The kinematics from the different implant designs were thus significantly different; a controversial answer regarding the hypothesis posed. This means the “performance” must be different between these implants if installed “ideally” on the same patient with the PCL retained. Studies are worthwhile to determine if these differences in performance are reflected in clinical functional conditions.

The restoration of pain-free stable function in gleno-humeral arthritic cases in various situations such as rotator cuff deficiency, old trauma and failed total shoulder arthroplasty is a challenging clinical dilemma. The Bayley-Walker shoulder has been designed specifically for very difficult cases where surface replacement devices do not provide sufficient stability. This device is a fixed-fulcrum reversed anatomy prosthesis consisting of a titanium glenoid component with a CoCrMo alloy head that articulates with an UHMWPE liner encased in a titanium alloy humeral component that has a long tapered grooved stem. The centre of rotation of the Bayley-Walker shoulder is placed medially and distally with respect to the normal shoulder in order to improve the efficiency of the abductor muscles. An important problem in devices of this type is obtaining secure and long-lasting fixation of the glenoid component. The glenoid component relies on fixation through the cortical bone by using threads, which protrude through the anterior surface of the scapula at the vault of the glenoid. It is HA coated for subsequent osseointegration. The purpose of this study was to investigate fixation of the glenoid component.

A 3D finite element model of the glenoid component implanted in a scapula was analysed using Abaqus. The implant was placed in position in the scapula, with the final 2–3 screw threads cutting through the cortical bone on the anterior side at the vault of the glenoid due to the anatomy in this region. The analysis was performed for two load cases at 60° and 90° abduction. A histological study of a retrieval case, obtained 121 days after implantation, was also conducted.

The FEA results showed that most of the forces were transmitted from the component to the cortical bone of the scapula, the remaining load being transmitted through cancellous bone. In particular the area where the threads of the glenoid component penetrated the scapula showed high strain energy densities. Histology from the retrieved case showed evidence of bone remodelling whereby new bone growth resulting in cortical remodelling had occurred around the threads.

Both the FEA and histological study show that fixing the component at multiple locations in cortical bone may overcome the problems of glenoid loosening associated with constrained devices. The Bayley-Walker device has been used on a custom basis since 1994; 81 Bayley–Walker shoulders for non-tumour conditions and 43 Bayley-Walker glenoid components have been used in association with a bone tumour implant, with good early results. Radiographically, radiolucencies have not been observed and overall the comparisons with the original Kessel design are positive.

We report the theoretical basis of a method to measure axial migration of femoral components of total hip replacements (THR). The use of the top of the greater trochanter and a lateral point on the collar of the stem, allowing for variations of up to 10 degrees rotation of the femur in any direction between successive radiographs, gave a maximum error of 0.37 mm. At a more realistic 5 degrees rotational variation, the error was only 0.13 mm. These data were confirmed in an experimental study using digitisation of points and special software. We also showed that the centre of the femoral head, the stem tip, and the lesser trochanter provided less accurate landmarks. In a second study we digitised a series of radiographs of 51 Charnley and 57 Stanmore THRs; the mean migration rates were found to be identical. We then studied 46 successful stems with a minimum follow-up of eight years and 46 stems which had failed by aseptic loosening at different times. At two years, the successful stems had migrated by a mean of 1.45 +/- 0.68 mm, but the failed cases had a mean migration of 4.32 +/- 2.58 mm (p < 0.0001). Of the successful cases 76% had migrated less than 2 mm, while in the failed group 84% had migrated more than 2 mm. For any particular case migration of more than 2.6 mm at two years had only a 5% chance of continuing success and would therefore merit special follow-up. Only 24% of the eventually successful stems showed migration at the stem-cement interface, but this had happened in every failed stem. We conclude that it would be possible to evaluate a new cemented design of femoral stem over a two-year period by the use of our method and to compare its performance against the reported known standard of the Charnley and Stanmore designs.

Forty failed hinged arthroplasties of the knee were revised by the insertion of another hinged implant. In 14 cases the prosthesis used at the revision operation was similar to the primary implant; in 26, a hinge with an elongated femoral stem was used, usually replacing part of the femoral shaft. In seven of these knees an elongated tibial stem was also required, though the tibial shaft was replaced in only two of them. There were many complications. Fracture of the femur at the tip of the femoral stem was the most frequent. Sixteen first revisions failed and were revised a second time; 12 required replacement of the distal femoral shaft and three required replacement of the proximal tibia. The incidence of complications in knees requiring a second revision was even higher. Four required a third revision after an average interval of three years. Failure of a hinged prosthesis results in bone loss mainly in the femur. Revision of a failed hinged prosthesis with another of the same design is unlikely to be successful and may cause fracture of the femur.

Experiments were carried out to determine the optimum conformity between the femoral and tibial condyles in condylar replacement knee prostheses. Wear tests and observations from removed prostheses indicated that both high and low conformity produced characteristic abrasion and fatigue. Partly conforming condyles provided stability under load-bearing but allowed laxity to occur. Fixation to resist the various forces on the tibial components was enhanced by a short central intramedullary peg. Partial conformity is proposed as the optimum configuration between femoral and tibial components.